The study will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies(AEP)among women 18 to 44 years of age living in Florida. The motivational intervention will significantly reduce more women''''s risk of an AEP than will an informational intervention aimed preventing Fetal Alcohol Syndrome.

Condition	Intervention	Phase
Alcohol Consumption Contraception Fetal Alcohol Syndrome	Behavior: Self-guided Motivational Intervention	Phase II

Further Study Details: 

Primary Outcomes: Significantly fewer alcohol exposed pregnancies; Reduced alcohol use; Effective contraception
Expected Total Enrollment:  800

The proposed project will evaluate the effectiveness of a media-based self-guided motivational intervention to reduce alcohol-exposed pregnancies (AEP). Participants will be women 18 to 44 years of age who are at risk of an AEP. The community targeted will be Florida. The intervention will be based on the investigators'''' previous experience in promoting self-change of drinking behavior at a community level and in promoting reduced risk for AEP through the use of a motivational intervention. Using a randomized group design, the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome (FAS). The FAS prevention condition will serve as a standard treatment control group in that most information available at the community level concerning the effects of alcohol on the developing fetus relate to FAS (e.g., warning labels on alcoholic beverage containers). It is suggested that many women at risk for AEP do not view themselves as at risk for FAS and therefore do not view FAS-oriented prevention messages as personally relevant. The proposed experimental design will evaluate a media-based strategy that could be easily implemented throughout communities. The proposed study design will have more methodological rigor and allow a more careful evaluation than would be possible if the intervention was initially targeted at the entire community.If successful the intervention results can be readily disseminated throughout the local area. Specific objectives are as follows:

1. Develop an evidence-based intervention to reduce alcohol-exposed pregnancies that can be easily disseminated at a community level through the mail and other media outlets.
2. Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs.
3. Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS.
4. Disseminate results of the study to health care providers in the local community.

Ages Eligible for Study:  18 Years   -   44 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Women aged 18 to 44 years who are not pregnant, not trying to become pregnant, and able to bear children.

At risk of an alcohol exposed pregnancy 90 days prior to the interview defined as (a) heterosexually active, (b) not effectively contracepting, and (c) drinking either ≥ 8 drinks per week on average or ≥ 5 drinks in a single day or both.

Contracepting effectively

Exclusion Criteria:

No alcohol consumption or vaginal intercourse in the 90 days prior to the interview Pregnant Trying to become pregnant Not able to bear children Contracepting effectively

Please refer to this study by ClinicalTrials.gov identifier  NCT00219336

Burt G Bolton, M.S.      954 262 5801    boltonbg@nova.edu
Linda C Bolton, Ph.D.      954 346-6974    sobelll@nova.edu

Florida
      Nova Southeastern University, Fort Lauderdale,  Florida,  33314,  United States

Study chairs or principal investigators

Linda C Sobell, Ph.D.,  Principal Investigator,  Nova Southeastern University   

Study ID Numbers:  U50/CCU300860; U50/CCU300860
Last Updated:  September 21, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00219336
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-27